FDA.reportPublic FDA data

510(k) K201286

Device
0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch
Applicant
Nurse Assist, LLC
510(k) number
K201286
Product code
NGT
Decision
Substantially Equivalent (SESE)
Decision date
2020-08-11
Date received
2020-05-14
Regulation
880.5200
Classification name
Saline, Vascular Access Flush
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Romeo Crisologo
Address
4409 Haltom Rd. Haltom City TX US 76117 76117

FDA Registration Numbers#

Source Documents#

510(k) summary PDF